QA Specialist-PM

Overview

Job Summary

• Collection, record, investigate and feedback on customer complaints to improve customer satisfaction, and impement and report on product recall and adverse event to comply with NMPA regulations.
• Responsible for suppliers management and distributor qualification checking.
• Collect and analyze quality data to feedback potential risk and quality improvement point.
• Support other functions on quality related matters.

Responsibilities

Key Accountabilities

• Responsible for handling customer complaint to continuously improve customer satisfication.
• Responsible for adverse event handling, including AE collecting, evaluation, reporting and product maintian in NMPA system.
• Responsible for product recall actions development, implementation and reporting.
• Responsible for quality training on complaint, adverse event and recall to ensure related activites implemenation effectively.
• Conduct customer satisfication survey as required.
• Undertake suppliers management and distributor qualification review.
• Collect and analyze quality data to feedback potiencial risk and opportunities for quality improvement.
• Prepare product periodic assessment reports and submit to NMPA in time.
• Backup for advertisement application and management.
• Backup for product quality checking and recording and handling with un-qualified products.
• Perform other tasks as assigned by line manager.

Qualifications

Minimum Knowledge & Experience required for the position

• Bachelor’s degree or above in Medical device specialty, medical Inspection, Biomedical engineering, Mechanical engineering, Clinical medicine, Pharmaceutical, Life Science, Chemistry, Quality Management, or related.
• Minimum 3-5 years quality working experience, medical device field preferred.
• Well understanding of related NMPA regulations.

If you are interested in constantly learning and being challenged on a daily basis, we encourage you to submit your resume or CV.

Werfen appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer